FENTANIL 50 MICROGRAMS/ML Roztwór do wstrzykiwań

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1. Fentanil Ethypharm 50 micrograms/ml, Injectable Solution
   1. What is Fentanil Ethypharm and what is it used for
   2. What you need to know before you are given Fentanil Ethypharm
   3. How to administer Fentanil Ethypharm
   4. Possible side effects
   5. How to store Fentanil Ethypharm
   6. Contents of the pack and other information

Fentanil Ethypharm 50 micrograms/ml, Injectable Solution

(fentanil)
Generic medicine
Read this leaflet carefully before you are given Fentanil Ethypharm.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Fentanil Ethypharm is and what it is used for
• 2. What you need to know before Fentanil Ethypharm is given to you
• 3. How to administer Fentanil Ethypharm
• 4. Possible side effects
• 5. How to store Fentanil Ethypharm
• 6. Contents of the pack and other information

1. What is Fentanil Ethypharm and what is it used for

Fentanil belongs to a group of medicines called opioid analgesics, often used in
anesthesia or as painkillers.
Fentanil Injection can be used in the following situations:

• At low doses, it is used to relieve pain during short-duration surgical procedures
• In case of assisted breathing, it is used at higher doses as an anesthetic and analgesic
• To relieve pain
• For the treatment of severe pain.

2. What you need to know before you are given Fentanil Ethypharm

You must not be given FentanilEthypharmif:

• you are allergic (hypersensitive) to fentanil, to other opioid medicines, or to any of the other ingredients of this medicine (listed in section 6)
• you suffer from asthma, shallow breathing or other breathing difficulties
• you are taking or have recently taken (within the last two weeks) any medicine for treating depression known as a monoamine oxidase inhibitor (MAOI) (see “Taking other medicines”)

Warnings and precautions
Speak to your doctor or nurse before receiving Fentanil Ethypharm if:

• you are pregnant, planning a pregnancy or breastfeeding
• your thyroid gland is underactive
• you suffer from lung disease
• you suffer from a muscle disease called myasthenia gravis
• you suffer from a liver or kidney disease
• you are undergoing opioid therapy or have previously abused opioids
• you suffer from alcoholism
• you suffer from severe, undiagnosed headache or have recently suffered a head injury
• you have been told you have low blood volume
• you experience pain in the upper right side of your abdomen (bile duct).
• you have been given Fentanil Injection during labour, as it may cause breathing problems in the newborn.
• you or anyone in your family has ever abused or been dependent on alcohol, prescription medicines or illegal substances (“addiction”).
• you are a smoker.
• you have ever had problems with your mood (depression, anxiety or a personality disorder) or have ever received treatment from a psychiatrist for another mental illness.

Repeated use of opioid pain relievers can make the medicine less effective (you get used to it). It can
also lead to dependence and abuse, which can lead to a life-threatening overdose. If you are worried
about becoming dependent on [medicine containing fentanyl], it is important to consult your doctor.
If any of these limitations may apply to you or your child, consult your doctor.

Special monitoring

• With repeated use of fentanyl, tolerance and dependence can develop.
• Your doctor will pay particular attention when giving you this medicine if you are elderly or debilitated due to illness, or are in labour.
• Fentanil Injection can cause slower than usual breathing or cause shortness of breath. This medicine will only be given to you in an environment where you can be closely monitored until normal breathing is restored.
• Your blood pressure and heart rate may also be monitored.

If treatment is stopped, withdrawal symptoms may occur. Inform your doctor or
nurse if you think this is happening to you (see also section 4. Possible side effects).

Other medicines and Fentanil Ethypharm:
The concurrent use of fentanyl and sedatives, such as benzodiazepines or related drugs,
increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can
be potentially fatal. For this reason, concurrent use should only be considered when other therapeutic options are not possible. In any case, if your doctor were to
prescribe fentanyl together with sedatives, they must limit the dose and duration of concomitant treatment.
Inform your doctor of any sedative medicine you are taking and strictly adhere to the dose recommended by your doctor. It may be helpful to ask friends or family to
pay attention to the signs and symptoms above. See your doctor if these symptoms occur.
Inform your doctor or nurse if you are using or have recently used any other
medicines, including those available over the counter.
Fentanil Injection must notbe used with medicines for the treatment of severe depression,
such as phenelzine or moclobemide, or if the use of such medicines has been stopped within the last
2 weeks. These medicines are known as monoamine oxidase inhibitors (MAOIs).
Tell your doctor or nurse if:

• you are taking selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) for depression (including citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine).
• you are taking any major tranquillizer (antipsychotic).
• you are taking some pain relievers for nerve pain (gabapentin and pregabalin).

Medicines that can interact with Fentanil Ethypharm include:

• CNS depressants (medicines that act on the brain and produce a feeling of drowsiness or weakness). These include sleeping pills, antihistamines (medicines used to treat allergies) that produce a feeling of drowsiness, medicines to treat certain mental disorders, other pain relievers or a general anaesthetic such as etomidate.
• ritonavir (medicine for the cure or prevention of viral infections, including HIV) and other protease inhibitors such as indinavir and saquinavir.
• droperidol (medicine used to treat anxiety and nausea)
• muscle relaxants
• medicines for the treatment of fungal infections, such as fluconazole or voriconazole
• midazolam (medicine used to promote relaxation and sedation before surgery)

It may be necessary to reduce the dose of etomidate and midazolam if administered together with
Fentanil Ethypharm .
Tell your doctor if you are taking any of the medicines listed above, as Fentanil
Injection may increase the effects of these medicines or impair their proper functioning.

Taking Fentanil Injection with food, drinks and alcohol:
You must not drink alcohol during treatment with Fentanil Ethypharm.

Pregnancy and breastfeeding:
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or nurse for advice before using this medicine.
Fentanil Injection must not be used during labour, as it may cause breathing problems in the newborn.
Fentanil is excreted in breast milk. You must not breastfeed or use expressed milk for 24
hours after administration of Fentanil Injection.

Driving and operating machinery:
Do not drive vehicles or operate machinery for at least 24 hours after administration of Fentanil
Ethypharm, as the medicine reduces attention. This medicine may affect your
ability to drive vehicles as it causes drowsiness or dizziness.

• Do not drive vehicles while taking this medicine until you have ascertained what the effects are on you.

Consult your doctor or pharmacist to find out if it is safe for you to drive vehicles during
taking this medicine.

Fentanil Injection contains sodium
If you need to control your salt intake (low-sodium diet), you should know that:

• Fentanil Ethypharm contains 3.5 mg of sodium per ml of solution, equivalent to 0.18% of the recommended daily intake of sodium through food for an adult.
• The contents of the vial may be diluted in a saline solution before administration. The saline solution also contains sodium

For those who engage in sporting activities: the use of the drug without therapeutic necessity constitutes doping
and may still result in a positive doping test.

3. How to administer Fentanil Ethypharm

This medicine is an injection and will be administered to you by your doctor. Your doctor will decide the
dose you need based on your age, your body weight, your health conditions, and any
other medicines you are taking.
Fentanil Ethypharm is administered into a vein via injection or infusion (intravenous drip). In
some circumstances, your doctor may prescribe a higher dose than the one indicated here.

Adults and children aged between 12 and 17 years:
During surgery with spontaneous breathing
The usual starting dose is between 50 and 200 micrograms, followed by a further dose of 50
micrograms if necessary.

During surgery with assisted breathing
The usual starting dose is between 300 and 3500 micrograms, followed by a further dose of
100-200 micrograms if necessary.

For infusion (intravenous drip)
The usual starting dose is 1 microgram per kilogram per minute for the first 10 minutes,
followed by a further dose of 0.1 micrograms per kilogram per minute for the duration
of the surgery. The intravenous drip is normally stopped 40 minutes before the end
of the surgery.

Elderly:
If you are elderly, you will be given a reduced dose.

Use in children aged between 2 and 11 years:
During surgery if your child is able to breathe spontaneously
The usual starting dose is between 1 and 3 micrograms per kilogram of body weight,
followed by a further dose of 1-1.25 micrograms per kilogram of body weight if
necessary.

During surgery if your child is undergoing assisted breathing
The usual starting dose is between 1 and 3 micrograms per kilogram of body weight,
followed by a further dose of between 1 and 1.25 micrograms per kilogram of body weight
if necessary.

If you receive more Fentanil Ethypharmthan you should:
Because Fentanil Ethypharm will be administered to you in hospital by a doctor, it is unlikely that
an overdose will occur; however, inform the doctor or nurse if you think you have received an
excessive amount of this medicine or if you begin to experience difficulty breathing, dizziness
or symptoms of low blood pressure or muscle stiffness. An overdose can also cause
a brain disorder known as toxic leukoencephalopathy.

4. Possible side effects

Like all medicines, Fentanil Injection can cause side effects, although not everybody gets them.
Contact your doctor or nurse immediatelyif you experience any of the following symptoms,
as it may indicate a serious allergic reaction.

• sudden onset of wheezing or chest tightness
• swelling of the eyelids, face or lips
• skin lumps or hives
• skin rash (red spots), itching, fever
• collapse

Very common side effects (which affect more than 1 in 10 people) include:

• muscle stiffness
• feeling sick (nausea) or being sick (vomiting)

Common side effects (which affect less than 1 in 10 people):

• feeling agitated
• jerky or uncoordinated movements
• drowsiness
• dizziness
• blurred vision, blind spots or halos around bright objects (vision disturbances)
• slowed or irregular heartbeat
• blood pressure unusually low or high
• pain at the site of the vein
• suffocation caused by spasms of the throat muscles
• wheezing or difficulty breathing
• stopping breathing for a short period of time. If necessary, your breathing may be assisted by a machine (ventilator).
• rash accompanied by itching or redness of the skin
• confusion

Uncommon side effects (which affect less than 1 in 100 people) include:

• excessive feeling of happiness (euphoria)
• headache
• swelling and blood clot at the site of a vein
• changes in blood pressure
• faster breathing than normal
• hiccups
• lowering of body temperature or chills
• breathing complications

Other side effects (frequency not known) include:

• severe allergic reaction (see the symptoms above)
• convulsions (fits or seizures)
• loss of consciousness
• muscle spasms
• stopping of the heart (cardiac arrest)
• slow or shallow breathing
• skin itching
• symptoms of withdrawal syndrome (may manifest with the onset of the following side effects: nausea, vomiting, diarrhoea, anxiety, chills, tremor and sweating)
• delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not there, sleep disturbances, nightmares)

Other side effects may occur if Fentanil Injection is used together with a
type of medicines called antipsychotics. These side effects include:

• chills or tremors
• restlessness
• feeling like you are seeing or hearing things that are not real (hallucinations)
• unusual movements, including shaking and agitation of hands and fingers, twisting of the body, shuffling when walking and stiffness of arms and legs

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Fentanil Ethypharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging and
on the vial label after ‘Exp./’. The expiry date refers to the last day of the month.
Do not use this medicine if you notice any changes in colour or the presence of particles. If
only partially used, discard any remaining solution.
Do not store at a temperature above 25°C and keep the container in the outer packaging to
protect it from light.

6. Contents of the pack and other information

What Fentanil Ethypharm contains
Active ingredient:fentanyl citrate 78.5 micrograms equivalent to 50 micrograms of fentanyl.

Other ingredients:sodium chloride, sodium hydroxide (for pH adjustment), water for injections

Description of the appearance of Fentanil Ethypharm and contents of the pack
The clear and colourless solution is contained in glass vials of 2 or 10 ml, in packs of 10 vials.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Ethypharm
194 Bureaux de la Colline, Bâtiment D
92213 Saint-Cloud CEDEX
France

Manufacturer:
Macarthys Laboratories Limited T/A Martindale Pharma
Bampton Road
Romford
Essex, RM3 8UG
United Kingdom
ETHYPHARM,
Chemin de la Poudriere, GRAND QUEVILLY,
76120, France

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Denmark: Fentanyl Ethypharm
Finland: Fentanyl Ethypharm 50 micrograms /ml injection solution
France:
Fentanyl Ethypharm 50 micrograms/mL, injectable solution
Germany: Fentanyl Ethypharm 50 Micrograms / ml Injection solution
Italy: Fentanil Ethypharm
Norway: Fentanyl Ethypharm
Spain: Fentanilo Ethypharm 50 mcg/ml solution for injection EFG
Sweden: Fentanyl Ethypharm 50 micrograms /ml injection fluid, solution
United Kingdom: Fentanyl 50 mcg/ml solution for injection